I. Field of the Invention
The present invention is directed generally to storage containers for packaging rather delicate flexible, elongate devices, particularly intravascular catheters, in coiled arrangement for shipment and prior to use. The invention more specifically relates to a packaging tray that benignly retains intravascular catheters, particularly delivery catheters, in a variety of french sizes and lengths in predetermined arrangement yet facilitates both the packing and removal of the devices in a manner that reduces the risk of damage to the catheter. The packaging tray of the invention can be inexpensively molded as a unitary piece preferrably from transparent polymeric material that enables packaged devices to be identified prior to opening.
II. Related Art
Intravascular catheters vary widely in length from about 100-120 cm to lengths up to 255 cm or more. These devices usually contain one or more internal lumens traversing this length. These devices are somewhat flexible, but are relatively thin and easily kinked if overflexed. Kinking of the devices, of course, may close or impede one or more of the internal lumens rendering the device unusable. Traditionally, intravascular catheters of many types have been packaged supported on long cardboard backing "cards" contained in sterile plastic wrap and a plurality of these are, in turn, packaged in stacked fashion in a paperboard box or the like which typically contains up to five catheters. Removal of the catheters from the box and from the plastic wrap on the cards can be awkward owing in part to the rather long thin nature of the catheter and damage during either operation historically has occurred too frequently.
An improved storage container or box which facilitates removing the catheter packages is illustrated and described in U.S. Pat. No. 5,402,886 to McGlinch, the inventor of the present invention, and assigned to the same assignee as the present invention, which solves part of the problem, however, improvements in the packaging of the catheter itself are also needed and these have only partially been met.
More recently, intravascular catheter devices have been packaged by being arranged in recesses in relatively flat covered trays which are dedicated to specific diameters or french sizes and lengths. With some arrangements, the elongated catheter bodies and dedicated distal working or delivery sections are retained in place snugly in recessed tray channels held by retention clips. While they successfully retain the catheters, the clips make loading and removal of the catheters inconvenient and have also shown a decided propensity to induce kinks in the catheter delivery system tubes, particularly during the removal process, which destroys their usefulness.
Clip-free systems have also been introduced. One of these is illustrated in FIGS. 1a and 1b which depict at 10 a shallow generally rectangular packaging tray characterized by an elevated perimeter edge 12 and a system of recessed channels formed within the perimeter of the tray. The channels are all of a common depth and include spaced, generally straight and parallel side channels 14 and 16 joined by end arcuate segments 18 and 20; one or more additional arcuate segments as at 22 and 24 are provided connecting the side channels and running generally parallel to end arcuate segment 18. As series of spaced short, integrally molded retention overhang or cantilevered corner segments are provided at 26, 28, 30 and 32 and a plurality of side segments are provided at 34. A shaped recess 36 is provided for the valve body. The straight section 16 is intended to accommodate the stainless steel tube extension attached to the proximal end of the catheter to which the valve body is attached. This can be seen best in FIG. 1a, the bottom of the channels 18-24 and particularly 18 and 20 are rounded and dedicated to receive a particular size or narrow range of french sizes of catheters. In addition, the overhang, depicted by 38, of the corner cantilevered retainers is quite pronounced and extends a significant distance into the channel.
While the tray of FIGS. 1a and 1b has generally been successful, it does have certain limitations and drawbacks that are significant. The channel arrangement limits the variety of catheter lengths which can be successfully stored to those which are within a narrow range of lengths storable in one pass about the tray and which do not require the distal segment to be stored as a straight section. In addition, as mentioned, the corner overhangs are significant. While the amount of the channels covered by the overhangs, as at 38, is not a particularly significant drawback in packing or loading the catheter into the tray, difficulties with this characteristic become apparent when one seeks to remove the catheter from the tray perhaps several months later. The catheters are somewhat flexible but tend to return to an established retained memoried shape. Thus, when a catheter is first wound or coiled in a fashion to fit into the peripheral channel of the tray, the coil is given potential or stored energy which tends to straighten it again. This causes the device to recoil against the exterior walls of the channels where it is retained by the cantilevers. After a period of time in storage, a catheter device then becomes set in the coiled position and, in order to remove the catheter from the tray, each of the corner overhangs now has to be avoided by urging or distorting the catheter shaft inward. In doing so, there is a danger of over-flexing or snagging and causing kinks in the catheter shaft.
Thus, there remains a need for an improved catheter packaging system that particularly facilitates removal of the packaged catheter thereby reducing the tendency or propensity of the devices to incur damage prior to use. A need is also present for a catheter packaging tray that can accommodate a wide variety of catheter french sizes and lengths and including delivery catheters that require a linear distal storage arrangement.
Accordingly, it is a primary object of the present invention to provide a packaging tray for storing an intravascular catheter device which allows easy loading and removal of the catheter without danger of kinking.
Another object of the present invention is to provide a catheter package that accommodates a wide variety of diameter (french sizes) and lengths of intravascular catheter devices.
Still another object of the present invention is to provide a catheter packaging tray that enables direct liftout of the catheter from the package.
A further object of the present invention is to provide a catheter packaging tray having the above attributes and advantages that is of a one-piece or unitary design.
A still further object of the present invention is to provide a one piece catheter packaging tray having the foregoing advantages that is transparent so that the contained catheter device can be readily identified without opening the package.
Other objects and advantages will become apparent with familiarity with the specification, drawings and appended claims.